Quality Culture From a company perspective Neil Sheahan

Quality Culture From a company perspective Neil Sheahan - QP Forum April 2018

Imagine…. If you could reduce errors made at your workplace? Deviations Investigations Reports Headaches Friday nights.

How to get your Company Passionate about Quality Leadership Message Credibility Quality Culture From a company perspective Quality Awareness Team. Enhance Quality Awareness & Ownership of Quality Employee Engagement Quality Culture

Golden Quality Rules Golden Rules remain visible as part of our Quality Culture Quality Leadership Lunch & Learn Informal lunch used to communicate what's ‘Current’ in GMP As per ICH Q 10, “Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. ”

Employee Engagement

Message Credibility Patient Talk Quality Awareness Week

2018 Road Map – Quality Awareness Jan • Data Integrity/Good Documentation Practice • QA Profiles. Jul • Quality Control • Good Laboratory Practices Feb • Audits • Reporting Aug • Facilities/ Equipment • Maintenance/ logbooks Mar Apr • Contamination Control • Good Hygiene • Training – GMP Training, Training in GMP Areas • Human Error Sep Oct • Release Procedure for Finished Products • Distribution • Computeris ed Systems GMP May Jun • Self Inspections • Quality Review • Qualified Person Nov • Good Housekeeping • Cleaning and Sanitation Dec • Material Management • Storage

Quality Culture No. Deviations /person/year 1. 40 1. 18/p/yr. 1. 20 1. 00 1. 10/p/yr. 0. 80 0. 60 1. 08/p/yr. 0. 40 0. 20 0. 92/p/yr. 0. 00 fy 14 fy 15 fy 16 fy 17 Not about Deviation Avoidance. Never linked with Quality Culture.

Quality Culture From a company perspective Increase personal responsibility and accountability for everyone involved in producing our pharmaceuticals

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